Diagnostic test element and process for its production
The invention concerns a process for producing a diagnostic test element for analyzing a body fluid in which a lancing member that can puncture a body part is provided with a collecting channel for body fluid obtained by the puncture, wherein the collecting channel exhibits capillary action, and wherein a sensor member for an optical or electrochemical measurement is connected to the lancing member. According to the invention, the sensor member and the lancing member can be joined together as interlocking connecting components wherein a measuring element of the sensor member is inserted into the collecting channel through an insertion opening of the lancing member.
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This application is a continuation of International Application No. PCT/US2007/065918, filed Apr. 4, 2007, which claims the benefit of International Application PCT/EP2006/009945, filed Oct. 15, 2006, which claims the benefit of European Application 05022535.8 filed Oct. 15, 2005, the entire disclosures of which are hereby incorporated by reference.
TECHNICAL FIELDThe invention generally concerns a process for producing a diagnostic test element suitable for analyzing a body fluid. The diagnostic test element has a lancing member that can puncture a body part to obtain a body fluid sample. The lancing member is provided with a capillary collecting channel for body fluid obtained by the puncture. The test element also has a sensor member for an optical or electrochemical measurement is connected to the lancing member.
BACKGROUNDBlood sugar self-monitoring is usually carried out several times daily as part of an insulin treatment regimen to control diabetes. It is therefore desirable to minimize the number of handling steps the patient is required to carry out and to ensure a relatively painless and highly reliable blood sugar measurement. Disposable measurement articles are used for hygienic reasons. In conventional blood sugar measurements, samples are generated by finger pricking with lancets and the measurement is carried out on separate detection elements. This requires a large number of handling steps by the patient which can result in errors. Further disadvantages are blood volumes that are too large, non-robust sample transfer procedures, and lack of integration that requires the patient to organize and handle separate devices and disposable supplies.
SUMMARYTaking this as a starting point, the object of the invention is to further improve the test elements and processes for their production known in the prior art, and in particular to enable practicable mass production and use of more highly integrated test elements that are cost-effective and at the same time reliable, while also allowing relatively simple instrument technology.
The combination of features stated in the independent claims is proposed to achieve this object. Advantageous embodiments and further developments of the invention are derived from the dependent claims.
The idea behind the invention is to use test elements in which a small volume sample can be collected and reliably analyzed. A production process is proposed for such test elements in which a lancing member that can puncture a body part is provided with a collecting channel, preferably exhibiting capillary action, for the body fluid obtained by the puncture, and a sensor member for an optical or electrochemical measurement is connected to the lancing member. According to the invention the sensor member and the lancing member are joined together as interlocking connecting components, such that a measuring element of the sensor member is inserted into the collecting channel through an insertion opening in the lancing member. This permits the parts to be separately produced in optimized manufacturing steps at low production costs and subsequently integrated into a compact configuration by a simple interlocking connection. In this configuration a small amount of sample in the collecting channel is sufficient to reliably contact and wet the sensor located therein. This also allows precise positioning tolerances in the test element production process, thereby simplifying tolerance management on the instrument side. In particular, it is not necessary to actively transfer the sample to a separate sensor that is not in the direct sample flow, thereby making possible reliable measurements, even with very small samples of 100 nanoliters or less. Reliable measurement is of special importance because automation of handling steps by the system reduces the demand of ability of the patient to monitor and control the process.
The invention is described in more detail in the following with reference to the embodiment examples shown schematically in the drawing.
The test elements 10 shown in the drawing can be used as consumables for blood sugar measurement in a hand-held device 12 designed for this purpose wherein glucose can be detected directly in the test element using a minimal amount of sample. For this purpose the test elements 10 comprise a lancing member 14 having a slot-shaped collecting channel 16, a sensor member 18 for an optical or electrochemical measurement in the collecting channel 16, and a holder 20 for the lancing member and the sensor member.
As illustrated in
As shown in
According to
Some specific methods for manufacturing test elements 10 configured in this manner are described in the following. In general the sensor member 18 and the lancing member 14 are joined in an interlocking manner whereby the measuring element 42 is inserted into the collecting channel 16.
In the embodiment according to
As shown in
In another manufacturing step illustrated in
It is also conceivable that the light guides or the reagent pad 48 are provided with a fluorescent indicator as described in the patent application WO 03/097859 and to which explicit reference is herewith made. Specifically, a liquid polymerizable composition comprising a detection reagent can be applied. After application of the sample to the front side of such a sensor, exciting light, e.g. UV light, is beamed in through a light guide. The fluorescence, e.g. bluelight, generated through the reaction of the analyte with the detection reagent in the polymer layer is detected via the light guide with a detector. Preferably, the polymer layer has a thickness of about 50 microns or less, which allows for comparably short reaction times for generating the fluorescence light when the analyte is detected. In this way, the reaction or measurement time can be shorter than 2 s, preferably shorter than 1 s, thereby enabling a measurement while the lancing member is still in the skin of the body part. It has been found that leaving the lancing member inserted for such a short time interval is fully acceptable for most users.
The embodiment shown in
A similar embodiment to
As also illustrated in
Special process steps are illustrated in
Firstly according to
The distal front end 86 of the composite part 54 is equipped with measuring elements in the rotary station 88 shown in
The composite parts 54 prepared in this manner are provided with lancing members 14 in the assembly station shown in
The metallic lancing members 14 can be provided with a hydrophilic layer in order to support the uptake of body fluid in the collecting channel 16. For this purpose the lancing members 14, either before or after they are mounted on the finally packaged test elements 10, can be brought into contact with an absorbent application ring 110 at the application station 108 shown in
A further possibility to produce the light fiber structure is to generate the fibers in situ on or within an embossed part of a tape or foil-like carrier. In this process a thin layer of low refractive index transparent polymer, for example epoxy, is deposited onto a structural substrate to form a base layer. This is then over-coated by a thin layer of photosensitive high refractive index transparent polymer. This layer is processed by UV photolithography to selectively remove material, leaving the light guides as generally parallel strips of high refractive index polymer bonded to the low refractive index base layer. Finally, a layer of low refractive index polymer is flow-coated over the light guides and polymerized to form a solid layer. The result is that high refractive index light guides are surrounded on all sides by lower refractive index transparent polymer, forming functional independent light guides. Suitable materials are available commercially, for example, under the tradenames EpoCore and EpoClad epoxy polymer resins supplied by the German company Micro Resist Technology. Particular advantages of such photolithographic processes for manufacturing the parallel light guides include low cost volume production and the ability to vary the geometry of the light guides along their length. For example, the light guides may be tapered to transition from a small reagent pad to a larger optical interface with the measuring instrument.
Claims
1. Process for producing a diagnostic test element for analyzing a body fluid in which a lancing member that can puncture a body part is provided with a capillary collecting channel for body fluid obtained by the puncture and a sensor member for an optical or electrochemical measurement is connected to the lancing member, wherein the sensor member and the lancing member can be joined together as interlocking connecting components wherein a measuring element of the sensor member is inserted into the collecting channel through an insertion opening of the lancing member, wherein the collecting channel is formed as a transverse continuous slot in the lancing member, said slot being open at a proximal aperture, wherein the sensor member is inserted into the slot through the proximal aperture for directly depositing the body fluid from the capillary channel directly onto the measuring element of the sensor member, wherein a holder positions the measuring element in the capillary collecting channel, wherein the capillary collecting channel establishes a path for directly depositing the body fluid on the sensor member, wherein the lancing member slot holds the diagnostic test element together.
2. Process according to claim 1, wherein the sensor member and the lancing member can be joined together along a connecting axis running in a longitudinal direction of the collecting channel.
3. Process according to claim 1, wherein the sensor member is inserted transversely into the collecting channel which has an open longitudinal side.
4. Process according to claim 1, wherein the collecting channel has a channel wall, wherein the measuring element in an interior of the collecting channel is arranged such that the measuring element is electrically isolated from the channel wall.
5. Process according to claim 1, wherein the measuring element protrudes in a self-supporting manner into an internal cross-section of the collecting channel.
6. Process according to claim 1, wherein the measuring element is arranged as a flow obstacle onto which the body fluid can flow in a proximal flow cross-section of the collecting channel.
7. Process according to claim 1, wherein the sensor member is connected to the lancing member by a clip, snap or latched connection.
8. Process according to claim 1, wherein the lancing member and the sensor member are connected together by a plug connection in which a proximal section of the lancing member is plugged into a receiving opening of the sensor member.
9. Process according to claim 1, wherein the sensor member is provided with a light guide in order to optically couple the sensor member to the measuring element.
10. Process according to claim 1, wherein a plurality of light guides are integrated into corresponding sections of a embossed support tape or substrate, and that each section of tape or substrate is connected to a lancing element.
11. Process according to claim 10, wherein the light guides are built during the integration step in situ by a photolithographic process.
12. Process according to claim 10, wherein the light guides have a variable cross-section over a length of the light guides.
13. Process according to claim 9, wherein the light guide that is fed from a reel and comprises a polymer fibre, is continuously combined with foil strips to form a composite.
14. Process according to claim 9, wherein the light guide is combined with a surrounding holding structure to form a composite part by means of a co-extrusion process.
15. Process according to claim 14, wherein an outer contour of the composite part is formed by embossing or embossing-cutting processes in order to receive the lancing element at a distal end of the continuous light guide composite and to enable a drive coupling and/or signal coupling at a proximal end of the continuous light guide composite.
16. Process according to claim 15, wherein individual structural units are cut to length from the composite part by laser cutting or mechanical cutting means.
17. Process according to claim 1, wherein the measuring element is provided as a section of reagent tape by dividing a reagent tape provided with test chemistry into pieces.
18. Process according to claim 1, wherein the measuring element is applied to an end face of the sensor member pointing towards the collecting channel in the connected state.
19. Process according to claim 1, wherein the measuring element is applied to the sensor member by a label application method in which the measuring element provided on a front side with a test reagent and on a rear side with an adhesive layer is prepared in the form of a self-adhesive label by dividing a tape into pieces.
20. Process according to claim 1, wherein the measuring element is formed by an end section of at least one electrode wire that is continuously coated with a test reagent.
21. Process according to claim 1, wherein the sensor member is formed by an electrochemical test strip, said test strip being provided with electrical conductor paths and at least one reagent field contacted by the conductor paths as a measuring element.
22. Process according to claim 21, wherein the test strip provided with longitudinal conductor paths is folded centrally and transversely whereby at least one measuring element is contacted with the conductor paths at the bending site.
23. Process according to claim 21, wherein primary conductor paths for an analyte detection and secondary conductor paths for an electrical continuity test of the primary conductor paths are applied to the test strip.
24. Process according to claim 1, wherein the measuring element includes at least two measuring elements that are in particular designed as reagent fields, are arranged in a measuring zone of the sensor member for a redundant duplicate measurement.
25. Process according to claim 1, wherein the measuring element is attached to the holder such that the measuring element overhangs distally and extends into the collecting channel, wherein the measuring element overhands more than 50 μm.
26. Process according to claim 1, wherein a guide means for inserting the lancing member is incorporated into the holder and is in particular in the form of a groove.
27. Process according to claim 1, wherein at least two parts of the holder are connected together while enclosing optical or electrical signal conductors, the holder parts being provided with recesses for the defined positioning of the signal conductors.
28. Process according to claim 1, wherein the lancing member is formed as a round or flat lancet by a cutting process and in particular by laser cutting or by an etching process.
29. Process according claim 1, wherein a hydrophilic layer is applied to the lancing member.
30. Process according to claim 1, wherein the lancing member is provided with a hydrophilic layer before being connected to the sensor member in an immersion bath or subsequently thereto preferably by spraying.
31. Process according to claim 1, wherein a plurality of test elements manufactured in a continuous process are packaged in a sterile manner as single-use articles in a magazine.
32. A process, comprising:
- providing a lancing member with a slot-shaped collecting channel and a forked-shaped proximal end, wherein the collecting channel is a slot that extends longitudinally along the lancing member from the forked-shaped proximal end to a distal end, wherein the fork-shaped proximal end has a proximal slit opening that opens on opposing sides of the lancing member, wherein the collecting channel is hydrophilic to draw fluid via capillary action, wherein the proximal slit of the forked shaped end and the collecting channel are formed in a unitary piece in which the proximal slit extends completely through the unitary piece and the collecting channel extends only partially through the unitary piece that forms the lancing member;
- securing a measuring element to a holder that includes receiving grooves to form a sensor member; and
- joining the sensor member to the lancing member in an interlocking fashion by mounting the forked-shaped proximal end of the lancing member into receiving grooves of the holder such that the sensor member is inserted into the slot-shaped collecting channel via the proximal slit opening at the forked-shaped proximal end of the lancing member, wherein the fork shaped end of the lancing member holds the sensor member and the lancing member together, and the collecting channel is aligned to deposit the fluid onto the sensor member via the fork shaped end.
33. The process of claim 32, wherein said providing the lancing member includes forming forked-shaped proximal end via a laser cutting process.
34. The process of claim 32, further comprising:
- wherein the sensor member has a reagent to analyze body fluid; and
- wherein said joining the sensor member to the lancing member includes inserting the reagent inside the slot-shaped collecting channel.
35. The process of claim 32, wherein said joining the sensor member to the lancing member includes inserting the sensor member into the slot-shaped collecting channel in an axial direction relative to the lancing member.
36. A process, comprising:
- providing a lancing member with a slot-shaped collecting channel and a forked-shaped proximal end, wherein the collecting channel is a slot that extends longitudinally along the lancing member from the forked-shaped proximal end to a distal end, wherein the fork-shaped proximal end has a proximal slit opening that opens on opposing sides of the lancing member, wherein the lancing member is made from a section of metallic wire, wherein the forked-shaped proximal end and the slot-shaped collecting channel are fabricated in the section of metallic wire;
- providing a sensor member configured to analyze body fluid, wherein the sensor member and the lancing member are separate components; and
- joining a sensor member directly to the lancing member through an interlocking connection by inserting the sensor member into the slot-shaped collecting channel via the proximal slit opening at the forked-shaped proximal end of the lancing member, wherein during said joining the forked-shaped proximal end holds together the sensor member and the lancing member, wherein the interlocking connection establishes a path for the body fluid to be deposited directly onto the sensor member from the slot-shaped collecting channel via capillary action.
37. The process of claim 36, further comprising:
- wherein the sensor member has a reagent to analyze body fluid; and
- wherein said joining the sensor member to the lancing member includes inserting the reagent inside the slot-shaped collecting channel.
38. The process of claim 36, further comprising:
- securing the sensor to a holder that includes receiving grooves; and
- mounting the forked-shaped proximal end of the lancing member into receiving grooves of the holder by inserting the sensor member into the slot-shaped collecting channel in an axial direction relative to the lancing member.
39. The process of claim 36, further comprising:
- forming a composite element with the sensor member and a holder;
- attaching a reagent pad to the sensor member; and
- wherein said joining the sensor member to the lancing member includes latching the reagent pad into the slot-shaped collecting channel via the proximal slit opening in a direction that is transverse to the lancing member.
40. The process of claim 36, further comprising:
- clamping the sensor member between two halves of a holder; and
- wherein the two halves of the holder clamped around the sensor member are inserted in the forked-shaped proximal end of the lancing member during said joining.
41. Process according to claim 1, further comprising:
- clamping the sensor member between two halves of a holder; and
- wherein the lancing member at the slot at least in part holds the two halves of the holder clamped around the sensor member.
42. The process of claim 32, further comprising:
- clamping the sensor member between two halves of a holder; and
- wherein the forked-shaped end at least in part holds the two halves of the holder clamped around the sensor member.
43. The process of claim 32, further comprising:
- prefabricating the forked shaped end and the collecting channel from a metallic wire, wherein the unitary piece is a portion of the metallic wire.
44. The process of claim 32, further comprising:
- treating the collecting channel to be hydrophilic.
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Type: Grant
Filed: Feb 20, 2009
Date of Patent: Nov 8, 2011
Patent Publication Number: 20090227898
Assignee: Roche Diagnostics Operations, Inc. (Indianapolis, IN)
Inventors: Hans-Peter Haar (Wiesloch), Karin Schwind (Schifferstadt), Michael Marquant (Mannheim), Nigel A. Surridge (Carmel, IN)
Primary Examiner: Max Hindenburg
Assistant Examiner: Michael C Stout
Attorney: Woodard, Emhardt, Moriarty, McNett & Henry LLP
Application Number: 12/389,778
International Classification: A61B 5/151 (20060101);